By Alastair Nicholson, Head of Co-ordination and Standardisation at the Health Research Authority
Co-ordinating and standardising the practice of research regulation is a huge priority for the Health Research Authority. The more the processes are joined up, the easier and quicker it is to do high-quality research that people can trust.
One thing that we know makes a big difference to researchers is speeding up the time it takes to set studies up.
Reworking processes that slow down how studies get up and running at individual sites is a large part of this, which is why we have been working with partner organisations across the UK to establish the National Contract Value Review (NCVR) process for commercial contract research.
Standardising and co-ordinating costing and contracting is an important part of the overall picture to make it quicker and easier to set up studies.
Lord O'Shaughnessy’s review of commercial clinical trials in the UK recognised the importance of NCVR and made it clear that we must build upon early success and expand the process.
Why is that important? It’s simple. The more clinical trials that we carry out in the UK, the better the treatments will be for patients.
What difference is NCVR making already?
NCVR has already helped us make a huge step in the right direction to improve the set-up of commercial studies.
The NIHR recently analysed data from 63 studies that took place in the past 12 months and found that study set-up times are now over 100 days quicker when compared to pre-pandemic levels. In practice, this means that study set-up time is being shortened by around four months through the changes introduced by NCVR.
The costing and contacting part of set-up activities for a clinical trial or study is now taking six months instead of 10 months. That’s a huge success and something that makes the UK a much more attractive place to come and do research.
By introducing an unmodifiable financial appendix to the suite of UK agreement templates, we have enabled the vision of no local contract-value negotiation. This creates a fairer system for research to be carried out across the UK, ensuring full cost recovery for all areas, accounting for the differing needs of local populations and health systems, whilst saving time and giving sponsors predictable costs to work with.
I want to say a huge thank you to everyone who shared feedback on the draft financial appendix and revised contract template. We received more than 800 comments from around 80 organisations, and that feedback has been invaluable.
All of the feedback was reviewed by the UK Four Nations Contracting Leads Group, and I think the changes are going to make a real difference to accelerating study set up. We will continue to work with colleagues from across the NHS and with industry to improve our templates and processes.
Working with industry partners has been fundamental to achieving change and it was great to hear that our approach has been valued by colleagues in industry.
Dr Jennifer Harris, ABPI Director of Research and Development Policy
Slow and variable set-up of industry clinical trials in the UK delays recruitment to trials, hindering patient access to innovative treatments. The National Contract Value Review uses a national, standardised approach, which reduces duplication and should speed up the set-up of trials.
Different parts of the jigsaw
Of course, study set-up is just one part of the jigsaw, and costing and contracting are only one part of study set-up.
It’s equally important to have the review and approval process for applications running smoothly.
We’re now in a position where the MHRA have caught up on their backlog and across the system we’re back on track. Things like combined review have already made a huge difference in speeding up the process.
The changes introduced as part of NCVR stage two came into effect on 1 October.
If you are involved in studies submitted using IRAS or the interactive costing tool (iCT) there are some practical things that you must now be doing.
You can take a look at the latest practical guidance in HRA Now and read more about the benefits of faster costing and contracting on the NIHR website.
Head of Co-ordination and Standardisation, Health Research Authority